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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 5X75MM LT W/BRNG C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 5X75MM LT W/BRNG C Back to Search Results
Catalog Number 114832
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 10/27/2020
Event Type  Injury  
Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
Event Description
Revision surgery - pin in ulna came loose.
 
Manufacturer Narrative
Corrected data: see g.1.Manufacturer narrative: the reason for this revision surgery was reported as loose ulna.The previous surgery and the surgery detailed in this event occurred 2.7 years apart.Initial or prolonged hospitalization was required.The healthcare professional indicated that there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records(dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to loose ulna.There were no findings during this evaluation that indicate the reported devices were defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
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Brand Name
DISCOVERY ELBOW
Type of Device
DISC ULNA 5X75MM LT W/BRNG C
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key10906686
MDR Text Key218491940
Report Number1644408-2020-01135
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K013042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/21/2020
Device Catalogue Number114832
Device Lot Number739840
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/25/2020
Supplement Dates Manufacturer Received02/18/2021
Supplement Dates FDA Received03/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
114700 LOT 522650
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
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